QST | Jotup

U.S. FDA Renews DILIsym® Software Licenses for 7th Year

Retrieved on:

Thursday, April 4, 2024

Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, said, “It is now known what properties to avoid to minimize liver toxicity in a new drug candidate -- but these same properties are often necessary to have therapeutic efficacy. By predicting safe dosing regimens of such drugs, DILIsym is now enabling successful development of important therapies that might otherwise be abandoned.”

Key Points:

DILIsym is the industry gold standard for quantitative systems toxicology (QST) software designed for the prediction and investigation of drug-induced liver injury (DILI).
The one-year renewal provides the FDA with continued access to the DILIsym platform for authorized employees across all FDA divisions.
It also allows the FDA to evaluate the potential DILI risk across multiple populations, which supports informed decision-making regarding drug approvals.
Companies interested in a free trial version of the DILIsym software can request it here .

Saudi Arabia Data Center Market Investment Analysis Report 2024-2029: Growth Opportunities in IT, Electrical, Mechanical Infrastructure, General Construction, and Tier Standards

Retrieved on:

Wednesday, March 13, 2024

Cloud, Microsoft, QST, Oracle Cloud, Saudi Telecom Company, Partnership, Telephone, Saudi Aramco, AWS, City, Amazon Web Services, Investment, STC, Arms industry

DUBLIN, March 13, 2024 /PRNewswire/ -- The "Saudi Arabia Data Center Market - Investment Analysis & Growth Opportunities 2024-2029" report has been added to ResearchAndMarkets.com's offering.

Key Points:

DUBLIN, March 13, 2024 /PRNewswire/ -- The "Saudi Arabia Data Center Market - Investment Analysis & Growth Opportunities 2024-2029" report has been added to ResearchAndMarkets.com's offering.
The Saudi Arabia data center market is expected to reach a value of $2.08 billion by 2028 from $1.31 billion in 2022, growing at a CAGR of 7.98% from 2022-2028
This report analyses the Saudi Arabia data center market share.
Riyadh is the primary location for investment in the Saudi Arabia data center market, followed by Jeddah, Dammam, and other cities.
Which all cities are included in Saudi Arabia data center market report?

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on:

Wednesday, February 14, 2024

Real-World Evidence, ACT, Data science, CMD, Toxicity, Budesonide, Paliperidone palmitate, Drug development, E20, RWE, ETF, Human, Pharmacology, Machine learning, Quantitative systems pharmacology, Register, Radiopharmaceutical, Legislation, QST, M12, CAT, Salt, Pharmacoepidemiology, Dasatinib, Algorithm, M13, Azacitidine, Methylphenidate, Clinical trial, Health, M&S, Methodology, PBPK, HMA, Adverse drug reaction, European, CHMP, HTA, Biomarker, Big data, Digoxin, Betahistine, Multi, Therapy, Medication package insert, Simulation, LALA, ADR, US FDA, Language, RWD, Corr, PBBM, WPS, SAWP, Committee, Pharmacovigilance, Peptide, ICH, CPS, Contribution, Good, QSP, Model, Epidemiology, Artificial intelligence, RPS, Research, Reproduction, PRAC, EMA, Health Canada, AI, Cross, Gastrointestinal tract, Paliperidone, Communication, Risk, Melatonin, MWP, CP, Medicine, Patient, Biostatistics, Pharmacokinetics, Oligonucleotide, E21, M14, Q&A, Drug, M15, Medical device

Industry level .................................................................................................. 13

Key Points:

Industry level .................................................................................................. 13
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

Page 2/14

1.
A reflection paper
(RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

Page 3/14

plan, and it is envisaged that something similar may be needed for other emerging treatment
modalities (e.g., peptides).
Guideline work led by other working parties
?
Revision of the guideline on the requirements for clinical documentation for orally inhaled
products (CPMP/EWP/4151/00 Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 4/14

The planned concept papers (CPs) will formulate problem statements for potential workshops and
subsequent guidance documents will be informed and enriched by the outcome of discussions of
workshops to be held in 2024.
Guideline work led by other working parties and committees
?
Revision of Guidance on the investigation of medicinal products in the term and preterm
neonate (EMEA/536810/2008).
There is a need for
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 5/14

new guidance in these areas to ensure these novel approaches meet the required evidentiary
standards and facilitate their evaluation.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 6/14

?

Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 7/14

?

Provide appropriate support to the EU network for generic and hybrid medicines including
product-specific requirements.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 8/14

2.3.
?
Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
based biopharmaceutics modelling (PBBM).
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 9/14

?

In order to support adequate evaluation of all methodology MWP will aim to facilitate an
increase in presence and visibility in relevant committees of methodological expertise from
across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 10/14

?

Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
depot) and melatonin have been prioritised as the next in series for drafting.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 11/14

4.2.
?
Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
assessment.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 12/14

?

To deliver an improved access to raw data (e.g.
?
Propose regulatory research priorities for funders in across the activities of Methodology
Working Party, including in the big data area.
?
Establish key communication points in national competent authorities and build a resource of
key messages and communication materials on regulation and methodology.
The timing of workshops may need to be arranged according to the
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

Page 13/14

specific needs of the guidance ? either before the guidance is finalised to gather views and
expertise; or once it is finalised for training purposes.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
Page 14/14

Quantum computer sources majority of components from Japanese makers

Retrieved on:

Wednesday, December 20, 2023

(SEC) today announced the successful development of Japan's third superconducting quantum computer (1) installed at Osaka University.

Key Points:

(SEC) today announced the successful development of Japan's third superconducting quantum computer (1) installed at Osaka University.
For the new quantum computer, the research team sourced more domestically manufactured components (excluding the refrigerator).
The research team confirmed that the new quantum computer, including its components, provides sufficient performance and will utilize the computer as a test bed for components made in Japan.
JPMXS 0118068682) and "Development of quantum software by intelligent quantum system design and its applications' (Team leader: Keisuke Fujii; Grant No.

OKI Develops GaN Lifting off/Bonding Technology on QST Substrates of Shin-Etsu Chemical

Retrieved on:

Monday, November 13, 2023

Semiconductor, Chemicals, Plastics, Technology, Manufacturing, Mobile, Wireless, Other Manufacturing, Hardware, Shin-Etsu Chemical, Head, Note 2, QST, CFB, Gallium nitride, Printed circuit board, OKI

This technology enables the vertical conduction of GaN and is expected to contribute to the realization and commercialization of vertical GaN power devices capable of controlling large currents.

Key Points:

This technology enables the vertical conduction of GaN and is expected to contribute to the realization and commercialization of vertical GaN power devices capable of controlling large currents.
On the other hand, OKI's CFB technology can lift off only the GaN functional layer from the QST substrate while maintaining high device characteristics.
Through this, the combined technologies of Shin-Etsu Chemical and OKI solve the above two major challenges, paving the way for the social implementation of vertical GaN power devices.
In the future, the two companies will contribute to the realization and widespread use of vertical GaN power devices through Shin-Etsu Chemical's provision of QST substrates or GaN grown QST substrates to companies manufacturing GaN devices and OKI's provision of CFB technology through partnering and licensing.

Latest in Lasers, LEDs, Automatic Captioning, and Virtual Production to Highlight SMPTE's Inaugural Emerging Technology Showcase

Retrieved on:

Monday, October 2, 2023

General Conference Session (Seventh-day Adventist Church), Court of general sessions, Aluminium, QST, Research, SMPTE, Projection, Showcase, AI, Summit, Conference, Calibration, Video game, Television

This stage, visible from all vantage points among the exhibitors in the Solutions Hub, will highlight groundbreaking solutions to the industry's biggest problems.

Key Points:

This stage, visible from all vantage points among the exhibitors in the Solutions Hub, will highlight groundbreaking solutions to the industry's biggest problems.
Live production partner The Studio-B&H will provide live capture systems for both the Emerging Technology Sessions and the General Conference Sessions.
Powered by AI, LEXI delivers results that rival human captions and seamlessly integrates with LEXI Viewer, an HD-SDI captioning device, for event presentations.
A full schedule of exhibiting companies and invited presentations will take place at the Emerging Technologies Showcase, including:

MHI Completes Final TF Coil for ITER

Retrieved on:

Thursday, August 24, 2023

Japan is responsible for the manufacture of nine of the total 19 TF coils for ITER, of which MHI handled the production of five coils.

Key Points:

Japan is responsible for the manufacture of nine of the total 19 TF coils for ITER, of which MHI handled the production of five coils.
MHI completed the world's first TF coil for ITER in January 2020 by bringing together the extensive knowledge it has cultivated over the years regarding mass production technologies for products with a high degree of manufacturing difficulty.
Japan is playing a major role in developing and manufacturing the core components of ITER, including the TF coils.
QST commenced R&D for the TF coil manufacturing technology in 2005, and MHI began their manufacture in 2012.

Questor Announces the Departure of President and CEO

Retrieved on:

Wednesday, August 23, 2023

QST, Management

CALGARY, Alberta, Aug. 23, 2023 (GLOBE NEWSWIRE) -- Questor Technology Inc. (“Questor” or the “Company”) (TSX-V: QST) announces the departure of President and CEO, Audrey Mascarenhas, effective today.

Key Points:

CALGARY, Alberta, Aug. 23, 2023 (GLOBE NEWSWIRE) -- Questor Technology Inc. (“Questor” or the “Company”) (TSX-V: QST) announces the departure of President and CEO, Audrey Mascarenhas, effective today.
Audrey joined Questor in 1999 and became CEO in 2005.
The Board of Directors is working on a transition plan that it expects to have completed in the near term.
During this transition period, Board member Derek O’Malley-Keyes will act as interim President and CEO to ensure an orderly transition to a new President and CEO.

Researchers Use the Simulations Plus DILIsym® Platform to Predict Safety of Combined CBD and VPA Treatment

Retrieved on:

Tuesday, August 15, 2023

CBD is an FDA-approved treatment for seizures in patients diagnosed with Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex.

Key Points:

CBD is an FDA-approved treatment for seizures in patients diagnosed with Dravet syndrome, Lennox-Gastaut syndrome, and tuberous sclerosis complex.
During the pre-approval clinical trials, treatment with CBD was occasionally associated with elevation in blood levels of ALT, a marker of liver injury, but this was much more common in patients already receiving treatment with VPA for seizures.
To identify potential underlying mechanisms, researchers used DILIsym to predict ALT levels in simulated populations that were treated with CBD alone, treated with VPA alone, and then treated with VPA before they were treated with CBD.
DILIsym predicted dose-dependent ALT elevations for CBD treatment and ALT elevations for VPA treatment when each was given alone, but the combined VPA and CBD treatment protocol mimicking the clinical trials did not increase the incidence of ALT elevations relative to CBD treatment on its own.

Saudi Arabia Data Center Market Investment Analysis Report 2023-2028: Opportunities in IT, Electrical, Mechanical Infrastructure, General Construction, and Tier Standards

Retrieved on:

Tuesday, July 4, 2023

Cloud, Amazon Web Services, Partnership, Investment, Telephone, QST, Microsoft, Saudi Aramco, RESEARCH, Oracle Cloud, City, Saudi Telecom Company, STC, AWS, Arms industry, Rail freight transport, Oil

DUBLIN, July 4, 2023 /PRNewswire/ -- The "Saudi Arabia Data Center Market - Investment Analysis & Growth Opportunities 2023-2028" report has been added to ResearchAndMarkets.com's offering.

Key Points:

DUBLIN, July 4, 2023 /PRNewswire/ -- The "Saudi Arabia Data Center Market - Investment Analysis & Growth Opportunities 2023-2028" report has been added to ResearchAndMarkets.com's offering.
The Saudi Arabia data center market is expected to reach a value of $2.08 billion by 2028 from $1.31 billion in 2022, growing at a CAGR of 7.98% from 2022-2028
This report analyses the Saudi Arabia data center market share.
Riyadh is the primary location for investment in the Saudi Arabia data center market, followed by Jeddah, Dammam, and other cities.
Which all cities are included in Saudi Arabia data center market report?